Last reviewed 2026-05-27 · How we verify

Cardunilizumab

Xiangya Hospital of Central South University · Phase 1 active Small molecule ✓ Verified May 2026

Cardunilizumab is a Small molecule drug developed by Xiangya Hospital of Central South University. It is currently in Phase 1 development. Also known as: PD-1/CTLA-4 Bispecific Antibody.

Cardunilizumab is a treatment being studied in a clinical trial for second-line treatment of sarcoma and soft tissue conditions. It is an anti-PD-1/CTLA-4 antibody, according to information from ClinicalTrials.gov and ChEMBL.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Cardunilizumab
Also known as	PD-1/CTLA-4 Bispecific Antibody
Sponsor	Xiangya Hospital of Central South University
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma (EARLY_PHASE1)
Cadonilimab (AK104) With or Without CT as 2rd Line Treatment for ES-SCLC (PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Cardunilizumab CI brief — competitive landscape report
Cardunilizumab updates RSS · CI watch RSS
Xiangya Hospital of Central South University portfolio CI

Frequently asked questions about Cardunilizumab

What is Cardunilizumab?

Cardunilizumab is a Small molecule drug developed by Xiangya Hospital of Central South University.

Who makes Cardunilizumab?

Cardunilizumab is developed by Xiangya Hospital of Central South University (see full Xiangya Hospital of Central South University pipeline at /company/xiangya-hospital-of-central-south-university).

Is Cardunilizumab also known as anything else?

Cardunilizumab is also known as PD-1/CTLA-4 Bispecific Antibody.

What development phase is Cardunilizumab in?

Cardunilizumab is in Phase 1.

Manufacturer: Xiangya Hospital of Central South University — full pipeline
Therapeutic area: All drugs in Other
Also known as: PD-1/CTLA-4 Bispecific Antibody

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing